Janssen COVID-19 Vaccine - EUA Fact Sheet for Healthcare ...

1 Revised: May/05/2022 1 FACT Sheet FOR Healthcare PROVIDERS ADMINISTERING Vaccine (VACCINATION PROVIDERS) EMERGENCY USE AUTHORIZATION (EUA) OF THE Janssen COVID-19 Vaccine TO PREVENT CORONAVIRUS DISEASE 2019 ( COVID-19 ) WARNING: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME See Full EUA Prescribing Information for complete warning. The Janssen COVID-19 Vaccine can cause thrombosis with thrombocytopenia syndrome (TTS) which may be life-threatening. TTS may involve thrombosis at unusual locations for a thrombus ( , cerebral vein, visceral artery or vein, extremity artery, central artery or vein) or in an extremity vein or pulmonary artery.

2 Among reported cases of TTS following administration of the Janssen COVID-19 Vaccine , symptoms began approximately one to two weeks after vaccination. Instruct Janssen COVID-19 Vaccine recipients to seek immediate medical attention for shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms (including severe or persistent headaches or blurred vision), or petechiae beyond the site of vaccination. The clinical course of TTS following administration of the Janssen COVID-19 Vaccine shares features with autoimmune heparin-induced thrombocytopenia.

3 In individuals with suspected TTS, the use of heparin may be harmful and alternative treatments may be needed. Do not administer the Janssen COVID-19 Vaccine to individuals with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 Vaccine . The Food and Drug administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, the Janssen COVID-19 Vaccine , for active immunization to prevent COVID-19 in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 Vaccine .

4 Revised: May/05/2022 2 SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all Vaccine administration errors , all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults, and cases of COVID-19 that result in hospitalization or death following administration of the Janssen COVID-19 Vaccine . See MANDATORY REQUIREMENTS FOR THE Janssen COVID-19 Vaccine administration UNDER EMERGENCY USE AUTHORIZATION for reporting requirements. The Janssen COVID-19 Vaccine is authorized for use under an EUA for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 Vaccine .

5 The Janssen COVID-19 Vaccine is a suspension for intramuscular injection. Primary Vaccination The primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose ( mL). Booster Dose A single Janssen COVID-19 Vaccine booster dose ( mL) may be administered at least 2 months after primary vaccination with the Janssen COVID-19 Vaccine . A single booster dose of the Janssen COVID-19 Vaccine ( mL) may be administered as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 Vaccine . The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the Vaccine used for primary vaccination.

6 See this Fact Sheet for instructions for preparation and administration . This Fact Sheet may have been updated. For the most recent Fact Sheet , please see For information on clinical trials that are testing the use of the Janssen COVID-19 Vaccine for active immunization against COVID-19 , please see DESCRIPTION OF COVID-19 Coronavirus disease 2019 ( COVID-19 ) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness.

7 Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea. Revised: May/05/2022 3 DOSAGE AND administration The storage and handling information in this Fact Sheet supersedes the storage and handling information on the carton and vial labels. Storage and Handling Storage Prior to First Puncture of the Vaccine Vial Store unpunctured multi-dose vials of the Janssen COVID-19 Vaccine at 2 C to 8 C (36 F to 46 F) and protect from light.

8 Do not store frozen. Unpunctured vials of Janssen COVID-19 Vaccine may be stored between 9 C to 25 C (47 F to 77 F) for up to 12 hours. The Janssen COVID-19 Vaccine is initially stored frozen by the manufacturer, then shipped at 2 C to 8 C (36 F to 46 F). If Vaccine is still frozen upon receipt, thaw at 2 C to 8 C (36 F to 46 F). If needed immediately, thaw at room temperature (maximally 25 C/77 F). At room temperature (maximally 25 C/77 F), a carton of 10 vials will take approximately 4 hours to thaw, and an individual vial will take approximately 1 hour to thaw. Do not refreeze once thawed. Storage After First Puncture of the Vaccine Vial After the first dose has been withdrawn, hold the vial between 2 to 8 C (36 to 46 F) for up to 6 hours or at room temperature (maximally 25 C/77 F) for up to 2 hours.

9 Discard the vial if Vaccine is not used within these times. Dosing and Schedule The Janssen COVID-19 Vaccine is authorized for use under an EUA for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 Vaccine . Primary Vaccination The primary vaccination regimen for the Janssen COVID-19 Vaccine is a single-dose ( mL).

10 Booster Dose A single Janssen COVID-19 Vaccine booster dose ( mL) may be administered at least 2 months after primary vaccination with the Janssen COVID-19 Vaccine . A single booster dose of the Janssen COVID-19 Vaccine ( mL) may be administered as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 Vaccine . The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the Vaccine used for primary vaccination. Revised: May/05/2022 4 Dose Preparation The Janssen COVID-19 Vaccine is a colorless to slightly yellow, clear to very opalescent suspension.